Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms

Summary

To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

Timeline

Start

2004-06

Primary completion

2005-04

Completion

2005-04

Publications

• Background Capo' JP Jr, Laramee C, Lucente V, Fakhoury A, Forero-Schwanhaeuser S. Solifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare Open-Label Trial. Int J Clin Pract. 2008 Jan;62(1):39-46. doi: 10.1111/j.1742-1241.2007.01644.x. Epub 2007 Nov 23.
• Background Mallett V, Burks D, Garely AD, Smith N. Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes. Curr Med Res Opin. 2007 Apr;23(4):821-31. doi: 10.1185/030079907x178847.
• Background Garely AD, Kaufman JM, Sand PK, Smith N, Andoh M. Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT). Clin Ther. 2006 Nov;28(11):1935-46. doi: 10.1016/j.clinthera.2006.11.010.
• Background Garely AD, Lucente V, Vapnek J, Smith N. Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes. Ann Pharmacother. 2007 Mar;41(3):391-8. doi: 10.1345/aph.1H581. Epub 2007 Mar 6.
• Background Sand PK, Steers WD, Dmochowski R, Andoh M, Forero-Schwanhaeuser S. Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):667-75. doi: 10.1007/s00192-009-0840-y. Epub 2009 Mar 10.
• Capo' JP, Lucente V, Forero-Schwanhaeuser S, He W. Efficacy and tolerability of solifenacin in patients aged >/= 65 years with overactive bladder: post-hoc analysis of 2 open-label studies. Postgrad Med. 2011 Jan;123(1):94-104. doi: 10.3810/pgm.2011.01.2250.

Drugs

Indications